The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures

Status: Unknown status
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients who are at least 18 years of age and who have closed epiphyses.

• Patients of both genders and all races.

• Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation.

• Patients with a history of an acute injury and an acute Jones fracture defined by Torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress.

• Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks.

• Patients with a baseline visual analog scale (VAS) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight.

• Patients who are in good general health and who have physical examinations that either are within normal limits or are clinically non-significant as determined by the investigator.

• Patients with laboratory evaluations that either are within normal limits or are clinically non-significant as determined by the investigator.

• Patients who have voluntarily signed informed consent forms, including HIPAA Authorization.

Locations
United States
Ohio
Ohio Orthopedic Center of Excellence
Recruiting
Upper Arlington
Contact Information
Primary
Peter H. Edwards, Jr., MD
LArnott@ohio-ortho.com
614-827-8700
Time Frame
Start Date: July 2010
Completion Date: April 2014
Participants
Target number of participants: 38
Treatments
Experimental: Teriparatide
Patients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
Placebo Comparator: Placebo Control
Patients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
Sponsors
Collaborators: Eli Lilly and Company
Leads: Ohio Orthopedic Center of Excellence

This content was sourced from clinicaltrials.gov

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